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Diabetes-related improvements for the youths and their parents (e.g., diabetes responsibility, adherence, and parent-child interactions) from baseline to post-treatment, maintenance of these changes over the 2 and 4 month follow-up.

Original Primary Outcome Measures ICMJE (submitted: June 20, 2012)

Diabetes-related Outcomes [ Time Frame: 4 years ]

Diabetes-related improvements for the youths and their parents (e.g., diabetes responsibility, adherence, and parent-child interactions) from baseline to post-treatment, maintenance of these changes over the 2 and 4 month follow-up.

Medical improvements for youth (e.g., HbA1c) pre- to post-treatment and maintained at 6 months after the last booster session. Decreased health care utilization for the youth (e.g., emergency room visits and inpatient hospitalizations) pre- to post-treatment and maintained at 6 months after the last booster session.

Original Secondary Outcome Measures ICMJE (submitted: June 20, 2012)

Diabetes-related medical outcome data [ Time Frame: 4 years ]

Medical improvements for youth (e.g., HbA1c) pre- to post-treatment and maintained at 6 months after the last booster session. Decreased health care utilization for the youth (e.g., emergency room visits and inpatient hospitalizations) pre- to post-treatment and maintained at 6 months after the last booster session.

In this research study the investigators want more about how being in a group about diabetes helps your family versus individual treatment. The investigators are asking youth with diabetes and their parents to be in the research, because the investigators want to see if this diabetes group and/or individual therapy is helpful to your coping, adjustment, and family communication about diabetes.

Detailed Description

The purpose of this research study is to find out what effects the Group Therapy Project has on parents and child's management of Type 1 Diabetes Mellitus (T1DM) from both a group versus an individual therapy modality. We want to start a group and individual therapy program that looks at youth and family adjustment and coping at the Cincinnati Children's Hospital with patients who have T1DM. There has been research before on this group therapy and we want to look at it in a "typical" clinical setting at Cincinnati Children's Hospital for both group and individual therapy. This research is being done to understand how a peer and family-based group versus individual therapy can be helpful by looking at survey data as well as medical data before and after participating in the diabetes therapy program. This information will help us further develop prevention and intervention programs for other youth with T1DM and their families.

Self-management Diabetes Protocol: Successful adjustment to daily diabetes management requires a wealth of clinical knowledge, solid problem-solving and coping skills to deal with the physical, social and emotional factors associated with caring for and living with a chronic illness, and motivation to take care of one's health.

Study Arms

Experimental: Group Therapy

This study includes having an initial assessment completed; participating in a 6 session group therapy intervention over a 7 week time period; and returning at 2 and 4 months after group therapy intervention for "booster" follow-up sessions. During the group intervention sessions, the parent group and the youth group will each meet for about 45 minutes and then the families will come together to work on family goals for the last 15 to 20 minutes.

Intervention: Behavioral: Group Therapy

Active Comparator: Individual Arm

This study includes having an initial assessment completed; participating in a 6 session group therapy intervention over a 7 week time period; and returning at 2 months after the individual therapy intervention for "booster" follow-up sessions and returning at only 2 months after the individual therapy intervention for the "booster" follow-up session. During the individual intervention sessions, the youth and the therapy will each meet for about 45 minutes and then the families will come together to work on family goals for the last 15 to 20 minutes.

Intervention: Behavioral: Group Therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Recruiting

Estimated Enrollment ICMJE

80

Estimated Completion Date

August 2020

Estimated Primary Completion Date

August 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Diagnosis of Type 1 Diabetes,

Aged 10.0 - 17.9 years of age,

At least one parent/caregiver to participate with them,

Diagnosed for at least 6 months.

Exclusion Criteria:

Potential participants will be excluded if:

They have a co-existing diagnosis of mental retardation, pervasive developmental disorder, substance abuse, eating disorders, psychosis, or other acute psychiatric or medical needs, such as suicidality